On April 10, 2009, the Association of Southeast Asian Nations (ASEAN) Economic Ministers signed the ASEAN Sectoral Mutual Recognition Arrangement (MRA) for Good Manufacturing Practice (GMP). When implemented, GMP certification and inspection reports received in one ASEAN member nation (in accordance with... Read More
Vietnam is currently attracting a great deal of foreign investment, especially from foreign medical device manufacturers that are relocating due to rising wages in coastal and southern China. American and European medical device makers dominate the market, but more and more global... Read More
Vietnam has recently moved to enhance its medical device regulatory system. While imported medical devices do not need to be registered in Vietnam to be marketed, they do require an import license. First-time device imports that use a novel method of diagnosis... Read More
Navigating global regulatory markets can be a challenge, particularly when multiple countries in a region differ in their rules. Playing by a common set of rules for medtech regulation is about to get a little easier in Southeast Asia, as a group... Read More
Managing Asian cultural and business diversity can be very complex for Western companies. Each country has its own culture, history, ideology, language and philosophy: a strategy in Taiwan may not work in China, and vice versa. Understanding the local mentality, beliefs, and... Read More
On June 24, 2008, Vietnam and the United States signed a memorandum of understanding (MOU) to enhance the safety of medical devices, drugs, food, and feed traded between the two nations. This MOU is a result of discussions between senior Vietnamese officials... Read More
At a recent Vietnam pharmaceutical industry meeting, healthy ministry officials stated that drug regulations needed to be ramped up and drug prices regulated more strictly. Vietnam’s pharmaceutical companies mostly manufacture generic products for simple illnesses. Many specialized drugs such as HIV and... Read More
ASEAN industry members assembled in the Philippines in January 2008 to announce committee members of the new ASEAN Medical Device Industry Association (AMDIA). AMDIA is focused on representing the common regulatory interest of the medical device industry in ASEAN. It will also... Read More
The Asian Harmonization Working Party (AHWP) has finalized two documents on the Safety Alert Dissemination System (SADS) on January 23, 2008. The main goals of SADS are the following: To define a structure for disseminating medical device safety alerts among AHWP members;... Read More
After joining the WTO in January 2007, Vietnam has seen a sharp increase in foreign investment in its pharmaceutical industry. In 2007 alone, there were 58 new foreign businesses in this industry. Vietnam’s Ministry of Health reported that by the end of... Read More